ACETAMINOPHEN REGULAR STRENGTH- acetaminophen tablet 
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Acetaminophen Regular Strength

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Do not use

  • with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical  attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours as needed
  • do not take more than 8 tablets in 24 hours
  • do not take for more than 10 days unless directed by a doctor
children 6-11 years
  • take 1 tablets every 4 to 6 hours as needed
  • do not take more than 4 tablets in 24 hours
  • do not take for more than 5 days unless directed by a doctor
children under 6 years do not use this adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information

Inactive ingredients

Corn starch, pregelatinized starch, stearic acid, may contain povidone, sodium starch glycolate

Questions?

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Acetaminophen Regular Strength

GENERIC: ACETAMINOPHEN

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-3416-0

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 11 mm

IMPRINT: AZ010

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

INACTIVE INGREDIENT(S):

Remedy_Label

ACETAMINOPHEN REGULAR STRENGTH 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-3416(NDC:54257-720)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code AZ010
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-3416-030 in 1 BLISTER PACK; Type 0: Not a Combination Product05/05/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/05/2022
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023
Document Id: 0783e95c-bd8f-49de-e063-6394a90afe29
Set id: 081de88c-3622-4796-83ef-f8dff210f061
Version: 2
Effective Time: 20231012
 
REMEDYREPACK INC.